Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01199289 | A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma | PHASE2 | COMPLETED | 315 | — | — | Oct 4, 2010 | Dec 21, 2011 | Nov 26, 2021 | 49 | United States, Austria +8 |
The ACQ is an instrument used in clinical research and practice to evaluate asthma control/impairment. It is a validated composite score that assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon awakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and forced expiratory volume in 1 second (FEV1). The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. The total score is obtained by adding the value from each question and dividing by the number of questions. Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive the matching placebo administered as subcutaneous (SC) injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10. |
| AMG 827 140 mg | EXPERIMENTAL | Participants will receive AMG 140 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10. |
| AMG 827 210 mg | EXPERIMENTAL | Participants will receive AMG 210 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10. |
| AMG 827 280 mg | EXPERIMENTAL | Participants will receive AMG 280 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10. |
| Name | Type | Description |
|---|---|---|
| AMG 827 | DRUG | SC injection. |
| Placebo | DRUG | SC injection. |
Inclusion Criteria: * Men or women 18 to 65 years of age * Percent of predicted FEV1 ≥ 50% and ≤ 80% * At least 12% reversibility over pre-bronchodilator FEV1 * Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone powder or equivalent * Ongoing asthma symptoms with ACQ composite score ≥...